Actively Recruiting
A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors
Led by China Medical University, China · Updated on 2024-03-06
9
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
C
China Medical University, China
Lead Sponsor
S
Shanghai First Song Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label clinical study of anti-HER2-CAR-T cells for HER2+ patients with locally advanced and/or metastatic solid tumors. In this study, a single-dose regimen was designed, and the investigator had the discretion to decide whether the patient received more than once CAR T-cell therapy.This study intends to include HER2+ patients with locally advanced and/or metastatic solid tumors.They will take the anti-HER2-CAR-T cell transfusion after a screening period, mononuclear cell (PBMC) collection, bridging therapy if necessary, and lymphocyte clearance pretreatment period.
CONDITIONS
Official Title
A Clinical Study Evaluating the Safety and Efficacy of Anti-HER2-CAR-T Cells Injection in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent forms and voluntarily participate
- Age 18 to less than 70 years, any gender
- Have locally advanced and/or metastatic HER2-positive solid tumors confirmed by tissue staining
- Histology-confirmed solid tumors such as breast, gastric, colorectal, pancreas cancer with ineffective or intolerable conventional treatments
- At least one measurable tumor lesion not exceeding 6 cm according to RECIST v1.1
- Expected survival of at least 12 weeks
- ECOG performance status of 2 or less
- Adequate blood cell counts including neutrophils, hemoglobin, platelets, and lymphocytes
- Adequate liver function with bilirubin and liver enzymes within specified limits
- Adequate kidney function with creatinine or creatinine clearance within limits
- Left ventricular ejection fraction (LVEF) of 50% or higher
- No breathing difficulties at rest and oxygen saturation over 90% on room air
- Sufficient intravenous access for blood cell collection without contraindications
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and 6 months after treatment
You will not qualify if you...
- Prior use of any CAR-T cell or genetically modified T cell therapies
- Waiting for or history of organ or stem cell transplantation
- Acute or uncontrolled active infections including tuberculosis
- Hepatitis B, hepatitis C, syphilis, or HIV infections as defined
- Low blood sodium or potassium levels below specified thresholds (may be corrected before participation)
- More than 50% of liver replaced by tumor on imaging
- Recent systemic steroid use above specified doses or immunosuppressive therapy
- Toxicity from previous anticancer treatments not recovered except alopecia or pigmentation
- Antibody or anti-PD-1/PD-L1 therapy within 4 weeks before blood collection
- Radiotherapy within 28 days before blood collection except limited local palliation
- Other malignant tumors within past 5 years except certain controlled skin or in situ cancers
- Active ulcers or gastrointestinal bleeding difficult to control
- Previous or current central nervous system tumors or diseases affecting safety
- Uncontrolled heart conditions or recent serious cardiac events
- Severe respiratory diseases including interstitial lung disease or active tuberculosis
- Active or past autoimmune diseases prone to relapse except specified exceptions
- Serious systemic diseases or complications affecting safety or compliance
- Recent major surgery or trauma without full recovery
- Allergies or intolerance to preconditioning or symptomatic treatment drugs
- Participation in other interventional clinical trials within 1 month
- Pregnant or lactating women
- Unwillingness or inability to use contraception or comply with study protocols
- Personnel involved in study design or conduct
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Phase I Clinical Trials Center Of The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
S
Shuhui Song, bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here